- Device
- Restylane® Refyne, Restylane® Defyne, Restylane® Kysse, Restylane® Contour
- Applicant
- Q-Med AB
- PMA number
- P140029
- Supplement
- S044
- Product code
- LMH
- Generic name
- Implant, dermal, for aesthetic use
- Decision date
- 2021-12-09
- Decision code
- OK30
- Date received
- 2021-11-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new supplier for ready-to-use solutions used in the manufacturing of Restylane Refyne, Restylane Defyne, Restylane Kysse, and Restylane Contour